The
section on International collaboration on GMP inspections has been updated in
regard to manufacturers of sterile medicines. EMA and its
European and international partners have launched a pilot programme to share
information on GMP inspections of manufacturers of sterile medicines located
outside the participating countries and to organise joint inspections of
manufacturing sites of common interest.
The
prerequisites for sterile products are:
- They are sterile (in all probability, based on the control of sterility
- assurance).
- Pyrogen free (apyrogenic).
- Free of visible particles
Other
key quality attributes for sterile products are:
- Chemical/biological
purity.
- Correct
dose/strength – correctly labelled .
- Correct
physical form e.g. colour, particle size, viscosity.
- No physical contaminants.
Batch release is
the process of reviewing and approving all pharmaceutical product manufacturing
and control records and it performed by the Quality Unit to determine
compliance with all established approved written procedures before a batch is
released. The process of batch release, and the authority and training of the
persons eligible to do so, varies according to different GMP systems.
The
products in scope include sterile medicines for human use of chemical origin
and certain therapeutic biotechnology - derived products, such as monoclonal
antibodies and recombinant proteins. Vaccines, cell and gene therapies and
plasma derived pharmaceuticals are currently out of the scope of this pilot.
Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)
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